Medical Director, Respiratory, Early Clinical Development

Are you ready to shape and deliver the AstraZeneca   Respiratory   pipeline?   If you are a motivated drug developer, this is an excellent time to join!   Who We Are    In the Respiratory Translational Sciences and   Clinical Development   (TSCD)   team, we are investigating the drivers of key respiratory diseases, with access to pioneering science, innovative drug discovery   approaches   and key collaborations with academic centers around the world. We are investigating a wide range of drug modalities – small molecules, biologics,   oligonucleotides   and   other modalities   – across multiple diseases with high unmet medical   need .   TSCD in R espiratory i s where science meets clinical drug development with a focus upon delivering innovative, early phase clinical studies (Phase 1 – Phase 2), while collaborating closely with our late phase clinical development colleagues who guide later phase clinical studies. We are a diverse team of experienced physicians,   clinical scientists   and translational   medicine   scientists   who collaborate with scientists and late clinical development to define our early phase clinical development strategies, design innovative clinical trials, develop and   validate   new clinical endpoints and translate scientific ideas to proof-of-concept studies in targeted patient populations.   What You Will Do    Asa Medical Director, you will provide medical and scientific input to preclinical and clinical stage assets   within the context of a   respiratory   clinical team.   This will include the creation of overall clinical development plans and clinical study design as   well writing   protocols, key study and health authority documentation, medical monitoring and ensuring   timely   delivery of studies, all in close collaboration with internal and external partners and clinical research organizations.   Experience in   Respiratory Medicine   is strongly preferred. The successful candidate will thrive in a fast-paced, proactive can-do culture, be   a strong communicator ,   and   a   collaborator.   Responsible for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans,   studies   and product in compliance with GCP.   Provide guidance in the medical strategy and clinical/disease   expertise   to Research, Translational Medicine, Early and Late-stage Clinical Development and Commercial colleagues as part of across functional teams.   Closely follow medical developments within   respiratory diseases   and   disseminate   new information   within Clinical Development and the wider   organization   to transform trends and emerging data into agile and innovative clinical plans.   Work closely and collaborate across early and late R&I clinical development, partner   functions   and wider AZ   organization   to ensure design and delivery of clinical development plans with high quality and speed.   Represent Early   Respiratory TSCD   to external partners, including Investigators, key external   experts   and patient advocacy groups.   Medical Lead for regulatory communication and preparation of   higher level   documents   Ensures internal and external peer review of potential study/program   design.   Support qualification of pharmacodynamic/disease markers for early assessment of efficacy.   Support   establishing   scientific collaborations with academic collaborators to support key advancing translational science activities   As available, provide clinical strategic input to in-licensing opportunities.   Basic Qualifications:   MD or PhD in   respiratory sciences  or related field Minimum of   5 years experience in industry or relevant clinical or research experience.   Understanding of the drug development process, including clinical and non-clinical study design and execution.   Understanding of clinical research   methodology   and biostatistics principles to   facilitate   innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules.   Understanding of FDA, MHRA and ICH GCP guidelines to ensure the   appropriate conduct   of global clinical studies in the United States,   Europe ,   an d   the   rest of   the   world.   Attention to detail, internal drive to generate high-quality work, and   sense   of passion and urgency to achieve team and program goals.   Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders   regarding   new strategies to ensure consistent communication.   Demonstrated   track record   in delivering results.   Outstanding verbal and written communication skills.   Excellent analytical, problem   solving   and strategic planning skills.   T he annual base salary for this position ranges from $249,827 - $374,740. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.   When we put unexpected teams in the same room, we unleash bold thinkin